Using imatinib to improve outcomes in gastrointestinal stromal tumors
A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
PHASE2 · University of Kentucky · NCT05493215
This study is testing if monitoring imatinib levels can help improve the quality of life for people with gastrointestinal stromal tumors while reducing side effects.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Drugs / interventions | imatinib, chemotherapy |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05493215 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients diagnosed with gastrointestinal stromal tumors (GIST) and aims to enhance their quality of life through therapeutic drug monitoring of imatinib. By assessing free drug levels and pharmacokinetics, the study seeks to ensure that patients maintain therapeutic levels of imatinib while minimizing side effects. Participants will be monitored for their response to treatment and any improvements in symptoms associated with GIST. The study is designed for patients who have recently started imatinib or are about to begin treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed GIST and specific mutations, currently receiving or about to start imatinib treatment.
Not a fit: Patients with the PDGFRA D842V mutation or those with uncontrolled illnesses or concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with GIST by optimizing imatinib therapy.
How similar studies have performed: Other studies have shown promise in using therapeutic drug monitoring for cancer treatments, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V) * Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month * Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease * Age ≥18 years * ECOG performance status of 0 or 1 * Normal organ function Exclusion Criteria: * Presence of PDGFRA D842V mutation * Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug * Concomitant anticoagulation with oral warfarin. * Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6 * Uncontrolled intercurrent illness * Concurrent malignancy
Where this trial is running
Lexington, Kentucky
- Markey Cancer Center — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Reema Patel, MD — University of Kentucky
- Study coordinator: Yvonne A Taul, RN
- Email: Yvonne.Taul@uky.edu
- Phone: 859-323-2354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Stromal Tumors